Method and device for disinfecting biological fluids and container for same

Abstract

A technique and receptacle for disinfecting biological fluids such as whole blood is described in which the disinfectant is prepositioned in a receptacle for biological fluids utilized for clinical evaluation in an amount which is sufficient to disinfect the fluid without interfering with subsequent clinical evaluation. The invention is specifically directed to disinfecting viral contaminants in blood by providing a closed container for the blood specimen which contains an amount of an aldehyde based disinfectant such as glutaraldehyde sufficient to destroy without otherwise affecting the integrity of the specimen for future evaluation. The amount of aldehyde based disinfectant positioned in the container is adjusted to provide an ultimate concentration in the blood specimen of aldehyde of about 0.1 to 2.5 weight percent and is buffered to a pH of about 7.2 to 8.5 percent preferably about 7.4. To increase the stability and shelf life of the sample container and disinfectant, activation or buffering to the indicated pH range does not take place until or just prior to introduction of the specimen into the container. In a particularly preferred embodiment of the invention, the closed sample container is evacuated and provided with an elastomeric stopper adapted to receive the hollow needle of a syringe whereby the blood specimen is introduced into the container directly from the donor.

What is claimed: 
     
       1. An evacuated receptacle for holding a specimen of biological fluid for clinical evaluation, comprising a vessel closed at one of its ends by an elastomeric stopper adapted to be penetrated by means for introducing said specimen therein, said vessel also containing prior to introduction of said specimen about 0.1 to 2.5 weight percent based on the total fluid and disinfectant of a disinfectant for viral infection present in the specimen which disinfectant is one or more compounds or mixtures thereof selected from the group consisting of glutaraldehyde and formaldehyde said disinfectant being buffered substantially at the time said biological fluid is introduced therein to a pH of about 7.2 to 8.5. 
     
     
       2. The receptacle of claim 1 in which said vessel also contains an activator for said disinfectant. 
     
     
       3. The receptacle of claim 1 wherein both ends of said vessel are closed by elastomeric stoppers. 
     
     
       4. The receptacle of claim 3 wherein both of said stoppers are provided with cavities adapted to retain material until said biological fluid is introduced into said receptacle, the stopper adapted for penetration by said means for introducing the fluid being also adapted to release said material retained therein on penetration, and the other of said stoppers being provided with separate means to release material contained therein into said receptacle. 
     
     
       5. The receptacle of claim 4 wherein the material retained in one of said stoppers is said disinfectant. 
     
     
       6. The receptacle of claim 5 wherein said disinfectant is glutaraldehyde and said biological fluid is blood, said glutaraldehyde being present in an amount such that introduction of said blood dilutes its concentration to about 0.1 to 2.5 weight percent based on the combined blood and glutaraldehyde. 
     
     
       7. The receptacle of the claim 5 wherein an alkaline buffering agent is also retained in one of said stoppers in an amount sufficient to adjust the pH of the blood in said receptacle to about 7.2 to 8.5. 
     
     
       8. The receptacle of claim 4 wherein said means to release material into the receptacle is an externally provided means for penetrating an envelope or barrier confining said material within said other stopper. 
     
     
       9. The receptacle of claim 8 wherein said penetration means is a pin. 
     
     
       10. the receptacle of claim 1 wherein said disinfectant is disposed in the end of said vessel remote from said stopper. 
     
     
       11. The receptacle of claim 10 wherein the concentration of said disinfectant is about 0.13 to 2.0 weight percent. 
     
     
       12. The receptacle of claim 1 wherein said disinfectant is coated onto the inside walls of said vessel. 
     
     
       13. The receptacle of claim 1 which also contains an effective amount of anticoagulant for said blood. 
     
     
       14. The receptacle of claim 1 which also includes an effective amount of a substance or substances to enhance cell permeability selected from the group consisting of dimethyl sulfoxide and glycerol. 
     
     
       15. The receptacle of claim 14 wherein an alkaline buffering agent is disposed therein and separated from said glutaraldehyde prior to introducing said biological fluid, in an amount sufficient to accomplish said buffering when said fluid is introduced into the receptacle. 
     
     
       16. The receptacle of claim 15 wherein either said disinfectant of said buffering agent is disposed in a cavity in said stopper such that introduction of biological fluid through said stopper causes said disinfectant or agent to be released into said vessel and whichever of the agent or disinfectant is not disposed in said stopper is otherwise present in said vessel. 
     
     
       17. The receptacle of claim 15 wherein said buffering agent is selected from the group consisting of sodium bicarbonate, sodium phenate, alkanols or 2-4 carbons, phenol, and quaternary ammonium compounds. 
     
     
       18. The receptacle of claim 1 wherein said disinfectant is buffered to a pH of about 7.4 by introduction of a said biological fluid and said fluid is blood. 
     
     
       19. In an evacuated receptacle for receiving and holding a specimen of blood for clinical evaluation comprising a closed vessel provided with at least one elastomeric stopper to effect said closure, the improvement which comprises: said receptacle containing prior to introduction of the blood an effective amount of glutaraldehyde such that introduction therein of said blood results in a glutaraldehyde concentration of about 0.1 to 2.5 weight percent based on the total of blood and glutaraldehyde and a pH of about 7.2 to 8.5. 
     
     
       20. The receptacle of claim 19 wherein an alkaline buffering agent is disposed therein separate from said glutaraldehyde prior to introducing said blood therein in an amount sufficient to accomplish buffering of the blood and glutaraldehyde to a pH of 7.2 to 8.5. 
     
     
       21. The receptacle of claim 19 wherein said at least one elastomeric stopper is adapted to receive a hollow syringe needle for introducing said blood into said receptacle. 
     
     
       22. A method for destroying viral contamination in a specimen of biological fluid which comprises providing an evacuated container for said fluid having predisposed therein an aldehyde or mixture of aldehydes in an amount sufficient to be lethal to said viral contamination in the biological fluid to be placed in said container without otherwise interfering with subsequent biomedical evaluation of said specimen, said amount of aldehyde being present in said container in a concentration of about 0.1 to 2.5 weight percent based on the total fluid and aldehyde and a pH of about 7.2 to 8.5. 
     
     
       23. The method of claim 22 wherein said biological fluid is blood. 
     
     
       24. An evacuated receptacle for receiving and retaining a specimen of blood for clinical evaluation, comprising a closed, elongated cylinder having an elastomeric stopper closing at least one of its ends and adapted to receive and be penetrated by means for introducing said blood specimen into said cylinder; the interior of said cylinder being provided prior to introducing said blood specimen with an aldehyde disinfectant for viral contamination and preservation of said specimen in an amount sufficient for said disinfection but insufficient to effect clinical evaluation of said specimen, the amount of said aldehyde beinig further sufficient to insure a concentration of about 0.1 to 2.5 weight percent based on the combined sample and disinfectant and a pH of about 7.2 to 8.5. 
     
     
       25. The receptacle of claim 24 which also contains separate from the aldehyde an alkaline buffering agent in an amount sufficient to result in said pH of 7.2 to 8.5 on introduction of said blood specimen. 
     
     
       26. The receptacle of claim 24 wherein said aldehyde is glutaraldehyde. 
     
     
       27. The receptacle of claim 24 in which said aldehyde is a mixture of formaldehyde and glutaraldehyde.